FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Private Equity Accelerating Consolidation In The CDMO Market
    Private Equity Accelerating Consolidation In The CDMO Market

    The CDMO industry has benefitted from big pharma’s divestment of in-house development and manufacturing capabilities in this current economic cycle. The sector has grown at a consistent 7 percent compound annual growth rate (CAGR) for the better part of a decade, outpacing that of the greater pharmaceutical industry itself. The rise of competition from new CDMO players and consolidation within the pharmaceutical sponsor space, however, has led to a crowded market and, in many cases, a commoditized service base.

  • Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods
    Cutting Packaging Costs: What Life Sciences Can Learn From Consumer Packaged Goods

    Industries can (and should) learn from one another. As the life sciences market continues to become more competitive and social pressure to reduce healthcare costs increases, consumer packaged goods (CPG) approaches and strategies to cut packaging costs can be applied to life sciences to achieve these objectives. 

  • IPR For Biosimilars: Examining The Benefits And Drawbacks
    IPR For Biosimilars: Examining The Benefits And Drawbacks

    Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

Securing Bioprocess Film Supply Securing Bioprocess Film Supply

Learn how a partnership built on technical expertise and trust is helping to secure the supply of a single-use film built for bioprocessing.

Is Your Partner Prepared For Your Scale-Up And Commercialization Challenges? Is Your Partner Prepared For Your Scale-Up And Commercialization Challenges?

Most early-stage companies are not equipped with the means necessary for successful scale-up and commercialization, so it is critical you find a partner that can help you overcome the inevitable challenges of drug development.

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

More Efficient Bispecific Antibody Purification With Fewer Steps

A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

How To Survive An FDA Audit

Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production

Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

More From OP White Papers - random

PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Efficient And Reliable Protein Purification

Biopharmaceutical manufacturer’s goals are to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial manufacturing. Traditionally, column packing has been considered a bottleneck. Suboptimal packing is not only time-consuming, but can result in poor performance. By eliminating these two concerns, you can focus on the core process.

Embrace Quality Risk Management To Build A Strong Quality Culture

Using QRM gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process

This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

Enhanced Cold Chain Capabilities

Along with proficient monitoring and tracking resources, Fisher Clinical Services optimizes every level of the cold chain process to ensure the security of clinical trial supplies.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

Louis Garguilo Articles

CONNECT WITH US


INDUSTRY INSIGHTS

  • Interacting With The FDA — Best Practices For Drug Development Success
    Interacting With The FDA — Best Practices For Drug Development Success

    When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?

  • 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs
    3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs

    In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”

  • How AI Tools Will Transform Quality Management In The Life Sciences
    How AI Tools Will Transform Quality Management In The Life Sciences

    FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.

  • Key Takeaways From The FDA’s New Continuous Manufacturing Guidance
    Key Takeaways From The FDA’s New Continuous Manufacturing Guidance

    The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

  • A Tactical Approach To Risk Management At The System-Level
    A Tactical Approach To Risk Management At The System-Level

    Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.

More Industry Insights

OUTSOURCING EVENTS

Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works July 30 - 30, 2019
2pm-3:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
FDA's eCTD Ad-Promo Guidance Is Finalized: Are You Ready? August 7 - 7, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error August 8 - 8, 2019
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in! August 13 - 13, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Quality Management Systems (QMS): Establishing A Practical & Compliant Program August 15 - 15, 2019
1pm-2:30pm EDT, Online Training
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events